← Product Code [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY) · K053626 # INTERX500 FLEXIBLE ARRAY ELECTRODE (K053626) _Neuro Resource Group, Inc. · GXY · Mar 29, 2006 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K053626 ## Device Facts - **Applicant:** Neuro Resource Group, Inc. - **Product Code:** [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY.md) - **Decision Date:** Mar 29, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1320 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation. ## Device Story InterX500 Flexible Array Electrode is an external accessory for Neuro Resource Group interactive electrostimulation devices; serves as extension to allow treatment of larger or less accessible body areas. Device consists of stainless steel electrodes embedded in biomedical grade silicone rubber; connected via two-conductor 24 AWG tinned copper wiring. No active electrical components; no power source; no conductive gels required. Placed directly on unbroken skin. Operated by clinician or user as part of electrostimulation system. Benefits patient by facilitating stimulation delivery to anatomical regions difficult to reach with standard device electrodes. ## Clinical Evidence Bench testing only. ## Technological Characteristics Passive electrode array; stainless steel electrodes in biomedical grade silicone rubber. Two-conductor 24 AWG tinned copper cable (UL/CSA approved). No active electrical components. Non-powered. Designed for surface application on unbroken skin without conductive gels. Connector is medically recognized and incompatible with AC sockets. ## Regulatory Identification A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. ## Predicate Devices - InterX 5000 ([K042912](/device/K042912.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date "MAR 2 9 2006". The month is March, the day is the 9th, and the year is 2006. The text is in a simple, sans-serif font and is left-aligned. Image /page/0/Picture/1 description: The image shows the logo for NRG. The logo consists of the letters "NRG" in a bold, sans-serif font, enclosed in a rectangular box with rounded corners. The letters are black, and the box is also black. There is a trademark symbol in the bottom right corner of the box. K053626 #### RESOURCE NEURO GROUP # 510(k) Summary Submitter Information: # Contact: Krista Oakes Tel: 972-665-1810 Fax: 972-665-1814 ## Date Prepared: December 19, 2005 # Product Name & Classification: Classification Regulation: 882.1320 Panel: Neurology, Physical Medicine Product Code: GXY Trade Name(s): InterX 500 Flexible Array Electrode ## Predicate Device: K042912-InterX 5000 ## Description: The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels. The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 9 2006 Neuro Resource Group c/o Ms. Krista Oakes Vice President, Regulatory Affairs 1100 Jupiter Road - Suite 190 Plano, Texas 75074 Re: K053626 Trade/Device Name: InterX500 Flexible Array Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GXY Dated: March 9, 2006 Received: March 15, 2006 Dear Ms. Oakes: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {2}------------------------------------------------ Page 2 - Ms. Krista Oakes forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Sincerely yours, Hubert Lenoir Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) # (if known): K053626 Device Name: InterX500 Flexible Array Electrode Indications for Use: The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation. Prescription Use x (21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hubert Lemonda Division of General, Restorative, and Neurological Devices **510(k) Number** K053624 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K053626](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K053626) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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